Nasal irrigation device and system with faux collapsible cartridge element

ABSTRACT

A nasal irrigation device communicates an irrigant to a device user and comprises a mechanics module and a reservoir assembly wherein a source of saline comprising a cartridge is disposed within the mechanics module adjacent a lid assembly for piercing the cartridge upon closing of a lid for releasing the cartridge contents into the reservoir assembly. A faux collapsible cartridge for testing operability of a nasal irrigation device comprises a housing including a shaft, a spring biased rod extending from the housing shaft, and a flange depending from a housing wall whereby the rod and flange are disposed to actuate a trigger assembly of the nasal irrigation device.

This application is a divisional of U.S. patent application Ser. No.17/860,601, filed Jul. 8, 2022, which is a continuation of U.S. patentapplication Ser. No. 16/543,920, filed Aug. 19, 2019, now U.S. Pat. No.11,413,377, which is a continuation of U.S. patent application Ser. No.15/783,730, filed Oct. 13, 2017, now U.S. Pat. No. 10,383,984, which isa divisional of U.S. patent application Ser. No. 13/551,274 filed Jul.17, 2012, now U.S. Pat. No. 9,833,380, which claims the priority benefitof U.S. Patent Application No. 61/508,767, filed Jul. 18, 2011. U.S.patent application Ser. No. 13/551,274 filed Jul. 17, 2012, is also acontinuation-in-part of U.S. patent application Ser. No. 13/276,448,filed Oct. 19, 2011, now U.S. Pat. No. 9,999,567, which is acontinuation of U.S. patent application Ser. No. 12/042,906, filed Mar.5, 2008, now U.S. Pat. No. 8,048,023, which claims priority from U.S.Patent Application No. 60/893,191, filed Mar. 6, 2007, and U.S. PatentApplication No. 60/895,180, filed Mar. 16, 2007. All are incorporated byreference in their entirety herein.

TECHNICAL FIELD

The presently disclosed embodiments generally relate to methods anddevices for lavaging, irrigating, rinsing, and hydrating the nasalcavity and anatomical openings thereto, generally and popularly known asnasal lavage or nasal irrigation.

BACKGROUND

Nasal and sinus disease and sinus related syndromes and symptoms are acommon clinical problem with considerable patient morbidity, substantialdirect costs, and a significant, negative impact on the quality of lifefor those who are afflicted. The four primary categories of afflictedgroups are: 1) individuals with acute and chronic rhinosinusitis; 2)individuals with upper respiratory infections, 3) individuals who sufferfrom allergic rhinitis; and 4) individuals with chronic snoringproblems. These four categories amount to millions of people who sufferfrom nasal congestion on a daily basis.

Bathing the nasal and sinus cavities with lightly-salted water to washaway encrusted mucous, irritants, and foreign particles, and to shrinkthe turbinates for the purpose of improving airflow and relieving nasalcongestion has been widely practiced across many cultures for literallythousands of years. More recently, and particularly since about 1990, asignificant number of peer-reviewed clinical trials have been undertakenat leading American and European medical schools and research centerstesting whether the anecdotal claims of relief from the symptoms ofnasal maladies as a result of practicing nasal irrigation, are wellfounded and pass scientific scrutiny.

These studies indicate that nasal irrigation is a clinically provenmethod for treating the symptoms of sinus-related disease by exposingthe nasal cavity to a streaming volume of saline. While the exactmechanism by which nasal irrigation's effectiveness is achieved is notyet well understood by the medical and scientific research community, itis likely multifaceted and includes a number of physiological effectswhich individually or in concert may result in an improved ability ofthe nasal mucosa to reduce the pathologic effects of inflammatorymediators and other triggers of allergic rhinitis, asthma and otherchronic mucosal reactions, as follows. First, it rinses the entireinterior of the nasal cavity, washing away encrustations that may beblocking the multiple ostia that connect the sinus cavities to the nasalcavity, thereby allowing the sinus cavities to properly drain into thenasal cavity and making the sinus cavities a much less attractivebreeding ground for the colonization of bacteria. Second, it decreasesthe viscosity of the mucous in the nasal cavity, thereby greatlyreducing the formation of interior encrustations. Third, it leaves asmall residue of saline on the interior surfaces of the nasal cavity,including the openings to the sinus cavities and sometimes in the sinuscavities themselves. This is beneficial because saline has an inherentlyantiseptic quality that hinders the growth of bacteria. Fourth, exposureof the turbinates, vascular tissue that warms and humidifies the airinspired through the nose before it reaches the lungs, to saline causesthem to reduce in size, thereby reducing nasal congestion. Fifth, itimproves mucociliary clearance as a result of increased ciliary beatfrequency, which improves the ability of the mucosa to perform itsnatural, flushing function. Sixth, the saline may wash away airbornebacteria, viral particles, irritants and other foreign particles thatcause infections and allergies.

There are two methods by which the nasal cavity can be irrigated:pressure that is positive relative to atmospheric pressure, and pressurethat is negative relative to atmospheric pressure. Positive pressure canbe effected two ways: first, by gravity, and second, by means ofmanufactured pressure. Negative pressure, also called vacuum or suction,can also be effected two ways: first, anatomically by nasal inhaling orsniffing, and second, by means of manufactured suction.

Positive pressure devices that rely on gravity allow the flow of salineinto the nasal cavity by, for example, inserting the tip of ateapot-like spout into one nostril and pouring the saline into it. Thesaline then flows around the posterior margin of the nasal septum andout the other nostril of the user. An example of a gravity-based deviceis the neti pot. However, the awkward physical position required toaccomplish such a rinse is difficult for many people, and the freeflowing effluent from the nasal passageway is messy so that substantialclean up procedures are necessary.

Positive pressure devices that rely on manufactured pressure pump thesaline into the nasal cavity, again, by introducing the saline into onenostril, forcing it under manufactured pressure around the posteriormargin of the nasal septum, and allowing it to drain out the othernostril. This can be achieved, for example, by placing the nozzle of asaline-filled, flexible plastic bottle into one nostril and squeezingit, thereby injecting the saline into one nostril, through the nasalcavity, and out the other nostril. This can also be achieved bysimilarly forcing saline into the nasal cavity under pressure created bya mechanical pump. Although this method avoids some of the physicalawkwardness needed to achieve a gravity forced flow, the problems ofmessiness and the attendant inconvenience of cleaning remain. Inaddition, the varied pressures imparted by a squeeze bottle can impartundesired, painful, and even harmful pressures throughout the nasalpassageway, and particularly on the Eustachian tube ostia. Thus, thisrequires some acquired skill for proper use.

Earlier nasal lavage devices that relied on negative, manufacturedpressure drew a saline solution through the nasal cavity by impartingsuction to a receptacle bottle or directly to the nasal cavity, but suchdevices are large, non-portable, complex, difficult to operate, andgenerally require the supervision and assistance for operation of anattending physician or medical assistant.

There is presently no practical device that offers a user the ability topractice nasal lavage using either or both positive and negativepressure, whether gravitational, anatomical, or manufactured, or anycombination thereof, in a single handheld collection device.

There is a need for a nasal irrigation device for communicating anirrigant to a device user comprising a mechanics module and a reservoirassembly wherein a source of saline comprising a cartridge is disposedwithin the mechanics module adjacent a lid assembly for piercing thecartridge upon closing of the lid for releasing the cartridge contentsinto the reservoir assembly.

There is a need for a convenient handheld device that can safelyirrigate the nasal cavity with a controlled, gentle supply, draw theirrigant through the nasal cavity under the influence of gentle poweredsuction, collect the effluent safely in a manner facilitating quick andeasy disposal, and is readily adaptable to a wide variety of nasaldimensions.

There is a need for a device that uses a readily transportable capsulefor effecting the filling of the device with irrigant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a nasal irrigationdevice and system;

FIG. 2 is an exploded view of the embodiment of FIG. 1 ;

FIG. 3 is a perspective view showing the embodiment of FIG. 1 with anopen lid and a saline concentrate capsule received in the device;

FIG. 4 is a cross sectional view of the embodiment of FIG. 1 ;

FIG. 5 is a partial sectional view showing lid closing operations;

FIG. 6 is a perspective view of the mechanical module, particularlyshowing the bottom wall thereof;

FIG. 7 is a perspective view of a saline concentrate capsule as may beused in the embodiment of FIG. 1 ;

FIG. 8 is an other view of the capsule of FIG. 7 ;

FIG. 9 is an embodiment of faux capsule element; and

FIG. 10 is a cross sectional view of the embodiment of FIG. 9 .

DETAILED DESCRIPTION

FIG. 1 shows a nasal irrigation device or controller A wherein apreferably saline solution is communicated to the nasal cavity of a userfor irrigating and washing the cavity, and upon departure from thecavity is collected in a collection reservoir. Such a saline basedtherapy is well known in itself, but the subject delivery system isnovel in that it uses a disposable cartridge concentrate supply forenhanced portability of the tool as opposed to a device that wouldrequire a bottle of saline solution. Such known systems have usedready-made supply bottles, or mixing of salt packs in squeeze bottles orneti pots. The irrigation device A is comprised of three principalcomponents, a mechanics module assembly 10, an upper reservoir assembly12 and a lower reservoir assembly 14. The mechanics module 10 includes anasal interface 20 for engaging the nostrils of a user with nasalpillows or nozzles 22 that are partially inserted into the nostrils andsealed against the opening perimeters thereof, as will be more fullyexplained below. An on/off switch 24 actuates a miniature pump forevacuating the lower reservoir 14 and applying differential pressure tothe lower reservoir 14 and the nasal cavity of a user, and a fluidrelease valve 72 (FIG. 4 ) to facilitate the flow of the saline throughthe whole fluid passageway from the upper reservoir to the lowerreservoir. Switch 24 is preferably a two stage actuator wherein a firststage starts the pump and the second stage opens the valve 72 to theflow of fluid from the upper reservoir, through the mechanics module andultimately to the lower reservoir. Saline mix to form an isotonic salinesolution for the irrigating results from water being poured into theupper reservoir 12 through opening of the hinged lid 26, and theinsertion of a saline concentrate capsule (FIG. 5 ) so that upon closingof the lid, the concentrate falls into mixture with the water.

FIG. 2 shows an exploded version of the assembly as the user mightdisassemble it for cleaning purposes. One can see therein that thenozzles 22 are intended to be received upon nozzle posts 28 dependingfrom a coaxial turntable mount 30 mounted for fluid sealing engagementon a coaxial turntable receiver 32 in a manner so that the irrigant canbe communicated first to one of the nostrils from a first one of thenozzles 22 and received from the nostril through a second nozzle 22. Thecoaxial turntable mount 30 is readily rotatable so that the direction offlow through the nasal cavity can be selectively reversed upon a desireof the user. One of the nozzles will always communicate fluid out of itregardless of turntable position, while the other nozzle will alwaysreceive fluid into it. Thus, a first nozzle is always in communicationwith the irrigant supply channel 33 in the interface, and the othernozzle is always in communication with the irrigant effluent channel 35.

The mechanics module assembly 10 is seen to include a cartridge orcapsule tower assembly 40 having the openable and closeable lid 26 topermit a disposable cartridge B, see FIG. 5 , to be received within thetower. FIG. 3 shows the lid 26 open and the capsule B being receivedtherein prior to lid closing and capsule piercing. An authentic capsuleB is one that is new and unused.

With continued reference to FIG. 2 , when assembled and loaded withirrigant, the system is intended to provide a closed system relative tofluid pressure when sealed against the nasal cavity of a user so that adifferential negative pressure resulting in a slight vacuum is appliedat the lower reservoir 14 to allow the fluid to fall from the upperreservoir 12 through the mechanical module 10, the nasal interface 30,and the nasal cavity of a user into the lower reservoir 14. The amountof differential pressure is relatively slight, just enough to overcomethe combination of human nasal cavity resistance and a declining headpressure due to the evacuating irrigant in the upper reservoir 12. Anegative pressure of something between 6 and 24 inches of water shouldbe adequate. It is important that the lower reservoir 14 be air-tightagainst the mechanics module 10. A bayonet twist mount is effective forthis objective including an elastomeric engagement seal 102 on the lowerwall of the module 10 contacting the upper outer rim of lower reservoiropening 42. Bayonets 44 can be seen to be disposed on the inlet flange43 are received in bayonet reception slots 37 in module outlet port 39(FIG. 6 ). The lower reservoir 14 also includes a plug 46 (FIG. 4 ) inits bottom wall for enhanced cleaning access to the interior of thereservoir. In operation, the lower reservoir is first inserted into themechanics module by alignment between the opening 42 and the module 10at a slight rotational angle, and then by effecting a slight rotation ofthe reservoir 14 to the position shown in FIG. 1 . A tactile “click”indicates to the user that the reservoir is properly sealed against themodule 10. Upper reservoir 12 is similarly applied to the mechanicsmodule 10 by a twisting click indication and similarly must be sealedagainst the module 10 with an elastomeric seal to preclude the irrigantfrom leaking out of the reservoir 12 either before or during use. It isnot important for the upper reservoir to be air-tight as air is intendedto be pulled into the upper reservoir as the fluid is evacuatedtherefrom to allow the irrigant to properly fall through the system.However, as can be seen with reference to FIGS. 1, 3 , and 4, the upperreservoir 12 is closely received about the tower assembly 40.

The lower wall 71 (FIG. 4 ) of the module 10 includes two fluid openingsopposite of opening 42. The first is a pump inlet port 73 for drawingair from the reservoir 12 by the pump 70, and the second is a fluidoutlet port 75 for allowing the irrigant effluent, which has cleaned theuser's nasal cavity, to fall into the reservoir 14. The air inlet portis protected against drawing irrigant into the module 10 by a floatvalve and cover 79. The batteries can be replaced through access door100.

With reference to FIGS. 3 and 5 , the lid 26 is opened through a pushbutton 50 typically comprising a latch and catch assembly. The lid 26includes engaging members 52, 54 specifically intended to engagepredetermined areas of the capsule B as an indicator that an authenticcapsule B is being used in the system by such members 52, 54 operatingin cooperation with the capsule and electrical and mechanical switchesto enable fluid flow and pump operation as will be more fully discussedbelow. The capsule B consists of a crushable plastic housing 63 and apierceable foil lid 65 that seals to the housing 63. The capsule towerassembly 40 has a recessed seat area 56 that mates with the overallouter configuration of the capsule for a close fitting of the capsulewithin the tower assembly to facilitate crushing, piercing, and propercamming operation. A plurality of teeth or blades 77 are included in theseat 56 to pierce the foil 65 upon the capsule compression and crushingthat results from the lid closing movement, thereby enabling the flow ofconcentrate therefrom. The capsule compression causes the sealingconcentrate to explode out of the capsule upon piercing, therebyfacilitating even irrigant mixing throughout.

With particular reference to FIGS. 4 and 5 the lock-out systems againsta non-authentic capsule are explained. Four different independentlockout actuators are involved in the subject embodiment, and it iswithin the scope of the intended embodiments to include any one, two,three, or four individually or in any combination to assure a user thatonly an authentic capsule is being used in the system.

The capsule B (FIGS. 6 and 7 ) includes a primary actuation button shownas triggering protrusion or button 64 and a secondary actuation flangeshown as a lower wall flange 66. Button 64 is intended to trigger switchactuator 60, and flange 66 is intended to actuate switch rod 62. As lid26 is closed, lid engaging member or trigger 54 will engage button 64causing trigger 54 to slide slightly backwards away from the capsule Bcausing slide 67 to also move over lever 69. As the lid 26 furthercloses, slide 67 will push down on linkage 60 for two independentresults. The end portion of the linkage 60 is disposed to move intoengagement and push away a physical lockout member (not shown) thatprecludes a user from pushing in the on/off switch 24. The failure tooperate the device A by successful movement of the on/off switch is thefirst protective independent actuator. The terminal end of the linkageis also disposed to engage a bellows cover of an electrical circuitinterrupt, normally open (not shown), upon lid closing. Failure of theinterrupt to be closed by the linkage 60 will preclude electrical powerto the system pump. Without evacuating air from the lower reservoir andthe fluid passageways, the irrigant cannot pass therethrough. Thelinkage circuit interrupt is the second protective independent actuator.

As the lid continues to close, engaging member 52 engages the flange 66causing flange 66 to press down on actuating rod 62 effecting a movementof the rod to also close a second circuit interrupt (not shown).Engaging member 52 comprises opposed engaging projections or surfaces52A, 52B spaced by recess 52C. The recess 52C is sized to allow theengaging member to pass over the terminal end 81 of rod 62 withoutmoving it when the lid is fully closed, unless an authentic flange 66bridges the surfaces 52A, 52B during the closing process. In otherwords, the engaging surfaces 52A, 52B actually only engage the flange66, which in turn will engage the terminal end 81, causing the push downof the rod 62 with the lid closing. A used or crushed capsule B willlikely have a deformation from the flange 66 original position, that maycause the flange to miss the end 81 during the closing. As noted, thepurpose of rod 62 movement is to cause the opposite terminal end (notshown) of rod 62 to engage a billows cover of a second circuitinterrupt, normally open (not shown), that will preclude power to thepump 70 unless closed. The successful cooperation between the flange 66,the rod 62 and the second circuit interrupt is the third independentsystem lockout actuator.

Irrigant cannot flow from the upper reservoir until valve 72 is opened.The on/off switch 24 is sized to engage a linkage (not shown) that willopen valve 72 as the switch 24 is pushed by the user to a fully onposition. As only an authentic capsule will permit the switch 24 to beactuated, the successful opening of the valve 72 by an authenticallyenabled on/off switch is the fourth independent lockout actuator.

Such a cooperating structure will ensure that only an authentic and aproperly mixed and sanitary concentrate is employed within the system.The operation is such that after an authentic capsule B has beenproperly inserted within the tower assembly, actuators 60 and 62 canenable both the on/off switch 24 and the pump 70. In operation, the userwill push on the on/off switch 24, first initiating the pump to beginevacuating air out of the lower reservoir 14. It can be seen that bothactuator assemblies are spring biased against enabling actuation. Aslight vacuum should then be felt by the user who has properly sealedthe interface at their nostrils. Continued pressing of the switch 24completes the mechanical linkage (not shown) in the module 10 tocompletely enable the opening of the valve 72 so the irrigant will thenbegin to flow through the fluid passageways of the mechanical module,through the nasal cavity of the user, and into the lower reservoir 14.The irrigating process continues until the fluid has been drained fromthe upper reservoir which is apparent to the user either by viewing thefluid through the transparent side walls of the upper reservoir, oruntil a sensation is detected that the system is no longer sealedagainst ambient air pressure by the pulling of ambient air through thevalve 72 as the upper reservoir 12 has been emptied. Electrical power tothe pump is provided by a battery pack 80 although a cord and plugembodiment with a rechargeable battery is alternatively possible.

It is within the scope of the intended embodiments to alternativelydispose electrical control systems, such as sensor and processor basedsystems, known to one of ordinary skill in the art, in place of selectedportions of the foregoing discreet lockout actuators.

FIG. 8 shows a better view of the capsule flange portion intended forengagement by engagement surfaces 52A, 52B. It can be seen that theflange is slightly extended over this portion and buttressed by ahousing buttress 59, although other buttress configurations could beemployed.

With particular reference to FIGS. 9 and 10 , a faux collapsiblecartridge embodiment or capsule is shown for testing operation of anembodiment of FIG. 1 . The faux cartridge or capsule 80 is comprised ofa housing 90 receiving a first spring biased rod 82 to simulate theeffect of button 64 of a capsule and a wall 84 to simulate the operationof the capsule flange 66. The faux capsule 80 is received in the towerassembly 40 of the mechanics module 10 so that as the lid 26 is closed,the terminal end of spring biased rod 82 will effectively enable triggerlinkage 60 just as button 64 of capsule B would have so triggered it andflange 84, will enable actuating rod 62 just as flange 66 would have.Upon the successful testing of a device A, the faux capsule 80 can beremoved from the device, and it can then be used to test a second andadditional devices A. Rod 82 is closely received in rod tube or shaft 86and biased to a fully extended position such as shown in the Figures byspring 88. The rod can be seen to extend from the housing of an angularoffset from a centerline of the housing which includes a side wall 92having a side wall slot 94 wherein a cross pin 96 retains the rod 82 inthe shaft 86. The slot 94 is sized to position the terminal end of rod82 at the proper functional position relative to engaging member 52.

It will be appreciated that variants of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be combined intomany other different systems or applications. Various presentlyunforeseen or unanticipated alternatives, modifications, variations orimprovements therein may be subsequently made by those skilled in theart which are also intended to be encompassed by the following claims.

1. A capsule simulator for use in association with a nasal irrigationdevice having a plurality of lockout actuators, comprising: a housinghaving a rod extending therefrom for simulating a crushable capsulebutton operation in association with a first lockout actuator, and awall for simulating a capsule flange operation in association with asecond lockout actuator.
 2. The capsule simulator of claim 1, whereinthe rod extends above the wall.
 3. A housing for use in association witha nasal irrigation device having a plurality of lockout actuators,comprising: a sidewall; a protrusion extending away from an upperperimeter of the sidewall, for triggering a first lockout actuator; anda lower wall flange extending away from a lower perimeter of thesidewall, for engaging a second lockout actuator.
 4. The capsulesimulator of claim 1, wherein the lower wall flange is buttressed by ahousing buttress.
 5. A method for using a nasal irrigation device,comprising: receiving the nasal irrigation device which comprises: amechanics module including a tower assembly comprising a lid; an upperreservoir disposed around the tower assembly; a lower reservoir belowthe mechanics module; filling the upper reservoir with an irrigant; andinserting a housing into the tower assembly that engages a plurality oflockout actuators to permit operation of the nasal irrigation device. 6.The method of claim 5, wherein the plurality of lockout actuatorsincludes a switch actuator which engages a lockout member that precludesa user from pushing in an on/off switch.
 7. The method of claim 5,wherein the nasal irrigation device further includes a pump within themechanics module, and wherein the switch actuator also closes a firstcircuit interrupt to enable an electrical circuit contact in themechanics module, permitting activation of the pump.
 8. The method ofclaim 5, wherein the plurality of lockout actuators includes a switchrod which engages a billows cover of a second circuit interrupt topermit activation of the pump.
 9. The method of claim 5, wherein thehousing comprises: a sidewall; a protrusion extending away from an upperperimeter of the sidewall, for engaging a first lockout actuator in theplurality of lockout actuators; and a lower wall flange extending awayfrom a lower perimeter of the sidewall, for engaging a second lockoutactuator in the plurality of lockout actuators.
 10. A delivery systemconfigured to deliver an associated irrigant as used in an associatednasal irrigation device from an associated device reservoir to anassociated device mechanics module, the associated device including anassociated first actuation device and an associated second actuationdevice in spaced relation thereto so that irrigant delivery is enabledin response to selective actuation of the associated first actuationdevice and the associated second actuation device operatively associatedwith first and second operative conditions of the associated device, thedelivery system comprising: a structure having: a first portionconfigured to operatively engage the associated first actuation device,and a second portion located in spaced relation to the first portion andconfigured to operatively engage the associated second actuation devicethat is located in spaced relation to the associated first actuationdevice such that the associated irrigant can flow through the deliverysystem upon operative engagement of both the first and second portionsof the structure.
 11. The delivery system of claim 10, wherein thedelivery system structure is a capsule or a faux cartridge.
 12. Thedelivery system of claim 11, wherein the faux cartridge of the deliverysystem structure includes the first portion extending from the structureand configured to engage the associated first actuation deviceindependently of the second portion.
 13. The delivery system of claim11, wherein the capsule of the delivery system structure includes thefirst portion extending from the structure and configured to engage theassociated first actuation device independently of the second portion.14. The delivery system of claim 13, wherein the capsule includes areservoir that is configured to receive at least a portion of theassociated irrigant therein.
 15. The delivery system of claim 11,wherein the capsule of the delivery system structure includes the secondportion located in spaced relation relative to the first portion. 16.The delivery system of claim 15, wherein the capsule includes areservoir that is configured to receive at least a portion of theassociated irrigant therein.
 17. The delivery system of claim 10,wherein the first portion protrudes from the structure and is one of abutton or rod configured to engage the associated first actuationdevice.
 18. The delivery system of claim 17, wherein the second portionincludes a flange configured to engage the associated second actuationdevice.
 19. The delivery system of claim 18, wherein the flange isbuttressed by a housing buttress.
 20. The delivery system of claim 10,wherein the structure cooperates with the associated nasal irrigationdevice so that the first and second portions can enable both anassociated on/off switch and an associated pump of the associated nasalirrigation device upon insertion of the structure into the associatednasal irrigation device.